Group member Amy Baxter, MD, is furious.

“I just got back from #PAINWeek where supposedly doctors are learning about what works for their patients to manage pain. We brought our new DuoTherm low back pain thermal/vibration prototypes – almost all the doctors cared about was drugs!

Let me tell you a little about Dr. Baxter.

Amy Baxter MD is an inventor, innovator, and pediatric emergency physician. She made Buzzy, which, to date, has blocked pain from 31 million needle procedures.

And she’s serious about drug-free pain relief. After Buzzy, she made VibraCool.

Then, in response to the repeated question, “When are you making one for the back?” she and her colleagues at PainCareLabs developed DuoTherm, now in the concept/prototyping stage and featured in an Indiegogo campaign through November 2018.

Why won’t you believe me?

The history of devices is paved with skepticism. For your entertainment, a 1930 video entitled, “Fat Men Use Mueller Exerciser Belt.” And, well, Theranos.

So you probably won’t be shocked to learn, of the $60 billion spent on U.S. pain management each year, only two of it is on devices.

Devices are at such a disadvantage versus medication that – get this – the family behind OxyCotin is now looking to market a milder opioids to help wean addicts off, well, opioids.

Amy’s company is doing its part to help: She tells me she does “seven figures” in annual sales and “a number of strategics” have talked with her.

Yet primary pain physicians aren’t won over yet. “Only two of 126 #PAINWeek presentations were about consumer devices,” Amy reported.

Turning the tide

“The first difficulty in turning the tide from pharma to device is, of course, reimbursement. Any prescription medication is fast tracked for coverage.

On the other hand, devices that work may not get paid for. Just last week, FDA announced a plan to give manufacturers clear guidance on what studies need to be done for payor reimbursement. This is extremely helpful, but underlies the huge hurdle of high quality studies.”

“In general,” Amy continued, “device research (especially for consumer devices) isn’t as rigorous as in pharma.

Why? Because:
• Pharma has more cash to get top researchers;
• Evaluating drug studies is familiar to most physicians; and,
• Even “real-world” case studies can undermine the device industry.”

Just one example, a device company study compared 800 compliant patients to 100 who self-selected out. They concluded those who stuck with the program, did better, evidence “the device works.” Uh huh. 🙄

Audaciously, the QR code accompanying their “scientific poster” took you to a “Buy a Device” page. 😠

Fighting the good fight

Primary pain physicians won’t be won overnight. But Dr. Baxter and her PainCareLabs team are in for the long haul with DuoTherm, their third pain management device.

Check out the IndieGogo campaign and, if you (or someone you love) is a back-pain sufferer, maybe get a unit at half price.

Thanks for reading and tell me what you think of this article, her concept, and the imbalance between device and pharma solutions in today’s comments.

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Jobs, Jobs, Medical Device Jobs!

Thank you for your warm response to the new Medical Devices Group Job Board last week.

Candidates can upload their resume and fill out a profile with links to sites of your choosing. And due to popular demand, medical device hiring managers can post a job for free through Thursday, September 13. Use code BETATEST at checkout.

I think it’s gonna be big.

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Also, we added a slick “Sharing” icon for each discussion. Use it to easily share items of interest over LinkedIn, Twitter, or email. I’m thrilled with the functionality.

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Thank you for being part of our Medical Devices Group community.

Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. Four weeks to go, and the group rate at the beautiful Hyatt Regency Mission Bay Spa and Marina expires next week. So if you’re flying in to San Diego for our 10x for ENGINEERS event, act today!